Status and Assessment Method of Nuclear Safety Analysis Software in China

In recent years, China’s nuclear power industry has enjoyed a good momentum of development, and related companies have also developed many nuclear analysis software applications. However, as the National Nuclear Safety Administration (NNSA, Chinese nuclear regulatory institution) did not approve any software before 2018, all these software applications were not evaluated formally, so they have not yet been used in reactor safety analysis. In order to solve this problem, in 2018, the National Nuclear Safety Administration started to carry out an engineering applicability evaluation for software developed by Chinese companies. After several years of review, as the first approved Chinese domestic software, core physics analysis software PCM developed by the China General Nuclear Power Group officially passed the software safety evaluation of the China Nuclear Safety Administration. This study will present the basic situation of the development of China’s nuclear power engineering software and introduce the framework, methods, procedures, requirements, and other aspects of China’s software safety evaluation work. The evaluation process and evaluation key issues of PCM software will also be illustrated.

Application of Software Reliability Model for Safety Assessment of E/E/PE Safety-Related Software

Quantitative and analytical safety assessment methods of E/E/PE safety-related software systems based on the SIL defined by IEC 61508 have been proposed. IEC 61508 does not provide us with quantitative and analytical methods for safety assessment of the software. Our methods give us quantitative information on safety measures for deciding the safety integrity level and testing time duration for achieving certain safety integrity level of E/E/PE software, respectively. Our stochastic modeling approaches are based on software reliability modeling and software reliability assessment techniques. Numerical examples for our methods have been shown for explaining how to use our software safety assessment approaches conforming IEC 61508.

Development a mathematical model for the software security testing first stage

This paper reports an analysis of the software (SW) safety testing techniques, as well as the models and methods for identifying vulnerabilities. An issue has been revealed related to the reasoned selection of modeling approaches at different stages of the software safety testing process and the identification of its vulnerabilities, which reduces the accuracy of the modeling results obtained. Two steps in the process of identifying software vulnerabilities have been identified. A mathematical model has been built for the process of preparing security testing, which differs from the known ones by a theoretically sound choice of the moment-generating functions when describing transitions from state to state. In addition, the mathematical model takes into consideration the capabilities and risks of the source code verification phase for cryptographic and other ways to protect data. These features generally improve the accuracy of modeling results and reduce input uncertainty in the second phase of software safety testing. An advanced security compliance algorithm has been developed, with a distinctive feature of the selection of laws and distribution parameters that describe individual state-to-state transitions for individual branches of Graphical Evaluation and Review Technique networks (GERT-networks). A GERT-network has been developed to prepare for security testing. A GERT-network for the process of checking the source code for cryptographic and other data protection methods has been developed. A graphic-analytical GERT model for the first phase of software safety testing has been developed. The expressions reported in this paper could be used to devise preliminary recommendations and possible ways to improve the effectiveness of software safety testing algorithms

Computer Life-Cycle Management System for Avionics Software as a Tool for Supporting the Sustainable Development of Air Transport

The article presents selected results of analytical and design works undertaken at the Air Force Institute of Technology (AFIT) in the field of building a computer support and software lifecycle management system that is critical for flight safety. The aim of the work undertaken is to develop methods and carry out verification and testing in order to detect errors in the developed avionics software for compliance with the requirements of the DO-178C standard and its production, certification, and implementation on board aircraft. The authors developed an original computer system within the implemented requirements used in the construction and certification of avionic onboard devices and their software (among others, DO-254, DO-178C, AQAP 2210, ARP 4761, ARP 4754A). The conducted analysis involved three basic groups of avionics software development processes, i.e., software planning, creation, and integration. Examples of solutions implemented in the constructed computer system were presented for each of these process groups. The theoretical basis of the new method for predicting vulnerabilities in the software implemented within integrated avionic systems using branching processes is discussed. It was demonstrated that the possibility of predicting vulnerabilities in future software versions could have a significant impact on assessing the risk associated with software safety in the course of its lifecycle. It was indicated that some of the existing quantitative models for analyzing software vulnerabilities were developed based on dedicated software data, which is why actual scenario implementation may be limited. DO-178C standard requirements for the process of developing avionics software were implemented in the helmet-mounted flight parameter display system constructed at AFIT. The requirements of the DO-178C and AQAP 2210 standards were shown to be met in the example of the software developed for a graphics computer, managing the operating modes of this system.

A preliminary clinical trial to evaluate 64Cu-NOTA-Trastuzumab as a positron emission tomography imaging agent in patients with breast cancer

Background The purpose of this study was to evaluate both the biodistribution and safety of 64Cu-1,4,7-triazacyclononane-1,4,7-triacetic acid (NOTA)-Trastuzumab, a novel 64Cu-labeled positron emission tomography (PET) tracer for human epidermal growth factor receptor 2 (HER2) in patients with breast cancer. Methods PET images at 1, 24, and 48 h after 296 MBq of 64Cu-NOTA-Trastuzumab injection were obtained from seven patients with breast cancer. Both the primary tumors’ and metastatic lesions’ maximum standardized uptake value (SUVmax) was evaluated. The mean SUVmax (SUVmean) was evaluated in the other organs, including the blood pool, liver, kidney, muscle, spleen, bladder, and the lungs, as well as the bones. Moreover, the internal radiation dosimetry was calculated using the OLINDA/EXM software. Safety was assessed based on feedback regarding adverse reactions and safety-related issues within 1 month after 64Cu-NOTA-Trastuzumab administration. Results 64Cu-NOTA-Trastuzumab PET images showed that the overall SUVmean values in each organ negatively correlated with time. The liver’s average SUVmean values were measured at 5.3 ± 0.7, 4.8 ± 0.6, and 4.4 ± 0.5 on 1 h, 24 h, and 48 h after injection, respectively. The average SUVmean blood values were measured at 13.1 ± 0.9, 9.1 ± 1.2, and 7.1 ± 1.9 on 1 h, 24 h, and 48 h after injection, respectively. The SUVmax of HER2-positive tumors was relatively higher than HER2-negative tumors (8.6 ± 5.1 and 5.2 ± 2.8 on 48 h after injection, respectively). Tumor-to-background ratios were higher in the HER2-positive tumors than in the HER2-negative tumors. No adverse events related to 64Cu-NOTA-Trastuzumab were reported. The calculated effective dose with a 296 MBq injection of 64Cu-NOTA-Trastuzumab was 2.96 mSv. The highest absorbed dose was observed in the liver (0.076 mGy/MBq), followed by the spleen (0.063 mGy/MBq), kidney (0.044 mGy/MBq), and heart wall (0.044 mGy/MBq). Conclusions 64Cu-NOTA-Trastuzumab showed a specific uptake at the HER2-expressing tumors, thus making it a feasible and safe monitoring tool of HER2 tumor status in patients with breast cancer. Trial registration CRIS, KCT0002790. Registered 02 February 2018, https://cris.nih.go.kr

A Preliminary Clinical Trial to Evaluate 64Cu-NOTA-Trastuzumab as a Positron Emission Tomography Imaging Agent in Patients with Breast Cancer

Background: The purpose of this study was to evaluate both the biodistribution and safety of 64Cu-1,4,7-triazacyclononane-1,4,7-triacetic acid (NOTA)-Trastuzumab, a novel 64Cu-labelled positron emission tomography (PET) tracer for human epidermal growth factor receptor 2 (HER2) in patients with breast cancer.Methods: PET images at 1, 24, and 48 h after 296 MBq of 64Cu-NOTA-Trastuzumab injection were obtained from seven patients with breast cancer. Both the primary tumors’ and metastatic lesions’ maximum standardized uptake value (SUVmax) was evaluated. The mean SUVmax (SUVmean) was evaluated in the other organs, including the blood pool, liver, kidney, muscle, spleen, bladder, and the lungs, as well as the bones. Moreover, the internal radiation dosimetry was calculated using the OLINDA/EXM software. Safety was assessed based on feedback regarding adverse reactions and safety-related issues within 1 month after 64Cu-NOTA-Trastuzumab administration.Results: 64Cu-NOTA-Trastuzumab PET images showed that the overall SUVmean values in each organ negatively correlated with time. The liver’s average SUVmean values were measured at 5.3 ± 0.7, 4.8 ± 0.6, and 4.4 ± 0.5 on 1 h, 24 h, and 48 h after injection, respectively. The average SUVmean blood values were measured at 13.1 ± 0.9, 9.1 ± 1.2, and 7.1 ± 1.9 on 1 h, 24 h, and 48 h after injection, respectively. The SUVmax of HER2-positive tumors were relatively higher than HER2-negative tumors (8.6 ± 5.1 and 5.2 ± 2.8 on 48 h after injection, respectively). Tumor-to-background ratios were higher in the HER2-positive tumors than in the HER2-negative tumors. No adverse events related to 64Cu-NOTA-Trastuzumab were reported. The calculated effective dose with a 296 MBq injection of 64Cu-NOTA-Trastuzumab was 2.96 mSv. The highest absorbed dose was observed in the liver (0.076 mGy/MBq), followed by the spleen (0.063 mGy/MBq), kidney (0.044 mGy/MBq), and heart wall (0.044 mGy/MBq).Conclusions: 64Cu-NOTA-Trastuzumab showed a specific uptake at the HER2-expressing tumors, thus making it a feasible and safe monitoring tool of HER2 tumor status in patients with breast cancer.Trial registration: CRIS, KCT0002790. Registered 02 February 2018, https://cris.nih.go.kr

Combined Assessment of Software Safety and Security Requirements

Safety is a fundamental concern in modern society, and security is a precondition for safety. Ensuring safety and security of complex integrated systems requires a coordinated approach that involve different stakeholder groups going beyond safety and security experts and system developers. The authors have therefore proposed CHASSIS (Combined Harm Assessment of Safety and Security for Information Systems), a method for collaborative determination of requirements for safe and secure systems. In this article, the authors evaluate CHASSIS through industrial case studies of two small-to-medium sized suppliers to the air-traffic management (ATM) sector. The results suggest that CHASSIS is easy to use, and that handling safety and security together provides benefits because techniques, information, and knowledge can be reused. The authors conclude that further exploration and development of CHASSIS is worthwhile, but that better documentation is needed—including more detailed process guidelines—to support elicitation of security and safety requirements and to systematically relate them to functional requirements.